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mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau (mimi)

This study is not yet open for participant recruitment.
Verified January 2016 by Bandim Health Project
Sponsor:
ClinicalTrials.gov Identifier:
NCT02662595
First Posted: January 25, 2016
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bandim Health Project
  Purpose

The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level.

The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention.

Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination.

A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.


Condition Intervention
Measles Other: SMS reminder message Other: Voice call + SMS message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • MV Coverage at 12 months of age [ Time Frame: 12 months of age ]
    Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.


Secondary Outcome Measures:
  • Timeliness [ Time Frame: At 12 months ]
    Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children.

  • Average number of visits [ Time Frame: At 12 months ]
    Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered.


Estimated Enrollment: 1050
Study Start Date: March 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: Text message
Subjects in this arm will receive a text message reminder in due time for measles vaccination.
Other: SMS reminder message
Active Comparator: Text message and voice call
Subjects in this arm will receive a voice call in addition to a text message reminder in due time for measles vaccination.
Other: Voice call + SMS message

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • the mother has access to a cell phone (either her own phone or the phone of a household member)
  • the mother lives in the uptake area of the health center.

Exclusion Criteria:

  • the mother does not have access to a mobile phone.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662595


Contacts
Contact: Emil Rossing, MA +2455772149 emro@ssi.dk
Contact: Amabélia Rodrigues, Dr. a.rodrigues@bandim.org

Locations
Guinea-Bissau
Varela Health Center Not yet recruiting
Varela, Cacheu, Guinea-Bissau
Paunca Health Center Not yet recruiting
Paunca, Gabú, Guinea-Bissau
Catio Health Center Not yet recruiting
Catío, Tombali, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT02662595     History of Changes
Other Study ID Numbers: MIMI-01
First Submitted: January 20, 2016
First Posted: January 25, 2016
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Bandim Health Project:
mHealth
mobile phones
measles vaccination

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs